NCT02013141

Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)

An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 12 Months to 17 Years

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 12 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes

Detailed description

This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes in male or female infants, children, and adolescents (\> 12 months to 17 years, inclusive) who require systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection. Blood samples for PK assessment will be taken as follows: 1.0 hour (±5 min), 1.5 hours (±5 min), 2 hours (±5 min), 6 hours (±30 min), 12 hours (±30 min) and 24 hours (±30 minutes) after the beginning of the infusion. The timing of PK sampling may be optimized after the completion of the older age groups (Cohorts 1-3) to assure that the minimum numbers of samples are collected in the youngest age group \> 12months to \< 24 months. Plasma exposures that will be compared to adult exposures are the primary assessment for this study. Subject safety will be monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, concomitant medication usage, and adverse event reporting.

Conditions

• Gram-Positive Bacterial Infections

Interventions

Type	Name	Description
DRUG	Telavancin

Timeline

• Start date: 2014-12-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2013-12-17
• Last updated: 2024-06-24
• Results posted: 2024-06-24

Locations

7 sites across 1 country: United States